In a general sense, the invention is directed to systems and methods for treating interior tissue regions of the body. More specifically, the invention is directed to systems and methods for treating dysfunction in body sphincters and adjoining tissue.
The gastrointestinal (GI) tract, also called the alimentary canal, is a long tube through which food is taken into the body and digested. The alimentary canal begins at the mouth, and includes the pharynx, esophagus, stomach, small and large intestines, and rectum. In human beings, this passage is about 30 feet (9 meters) long.
Small, ring-like muscles, called sphincters, surround portions of the alimentary canal. In a healthy person, these muscles contract or tighten in a coordinated fashion during eating and the ensuing digestive process, to temporarily close off one region of the alimentary canal from another region of the alimentary canal.
For example, a muscular ring called the lower esophageal sphincter (or LES) surrounds the opening between the esophagus and the stomach. Normally, the lower esophageal sphincter maintains a high-pressure zone between fifteen and thirty mm Hg above intragastric pressures inside the stomach.
In the rectum, two muscular rings, called the internal and external sphincter muscles, normally keep fecal material from leaving the anal canal. The external sphincter muscle is a voluntary muscle, and the internal sphincter muscle is an involuntary muscle. Together, by voluntary and involuntary action, these muscles normally contract to keep fecal material in the anal canal.
Dysfunction of a sphincter in the body can lead to internal damage or disease, discomfort, or otherwise adversely affect the quality of life. For example, if the lower esophageal sphincter fails to function properly, stomach acid may rise back into the esophagus. Heartburn or other disease symptoms, including damage to the esophagus, can occur. Gastrointestinal reflux disease (GERD) is a common disorder, characterized by spontaneous relaxation of the lower esophageal sphincter.
Damage to the external or internal sphincter muscles in the rectum can cause these sphincters to dysfunction or otherwise lose their tone, such that they can no longer sustain the essential fecal holding action. Fecal incontinence results, as fecal material can descend through the anal canal without warning, stimulating the sudden urge to defecate. The physical effects of fecal incontinence (i.e., the loss of normal control of the bowels and gas, liquid, and solid stool leakage from the rectum at unexpected times) can also cause embarrassment, shame, and a loss of confidence, and can further lead to mental depression.
The invention provides unified systems and methods for controlling use and operation of a family of different treatment devices.
One aspect of the invention provides systems and method for controlling operation of a family of treatment devices comprising at least first and second different treatment devices. In use, the different treatment devices are intended to be individually deployed in association with different tissue regions. According to this aspect of the invention, the systems and methods make use of a single, unified controller to which a selected one of the first or second treatment device is coupled for use. A reader downloads information to the controller to identify the selected treatment device that is coupled to the connector. The controller enables a first control function when the reader identifies the first treatment device as the selected treatment device. The controller enables a second control function when the reader identifies the second treatment device as the selected treatment device. The single, unified controller further includes an operating system to execute on a display screen different graphical interfaces, each tailored to the configuration and treatment objectives of the particular treatment device selected for use. A first graphical interface tailored for the first treatment device is executed when the first control function is enabled. A second graphical interface tailored for the second treatment device and different, at least in part, from the first graphical interface, is executed when the second control function is enabled.
The single, unified controller thereby makes possible the treatment of different regions of the body by different treatment devices.
Another aspect of the invention provides systems and methods for controlling operation of a treatment device. The systems and methods confirm by different mechanisms the identity of the treatment device intended to be used, before enabling such use. In one embodiment, the systems and methods provide a usage key card for the treatment device. The usage key card is adapted to be handled separate from the treatment device. The usage key card contains a storage medium formatted to contain an identification code that identifies the treatment device. The identification code is communicated by a reader to a controller to which the treatment device is coupled for use. The systems and methods also provide an electrical identification signal that is communicated by the treatment device itself to the controller when the treatment device is coupled to the controller for use. Before enabling use of the treatment device, the systems and methods cross-check the identity of the treatment device based upon the identification code and based upon the electrical identification signal. The systems and methods enable use of the treatment device only when the identity of the treatment device based upon identification code and the electrical identification signal corresponds. The systems and methods thereby provide a failsafe means for identifying the treatment device, using both software (i.e., the identification code on the usage key card) and hardware (i.e., the electrical identification signal provided by the device itself).
Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended claims.